Hepatic CancerNCT02649868
LC Bead LUMI Radio-Opaque Embolic Beads to Detect and Characterize the Vascularity of Hepatic Tumors
A study testing Transarterial embolization (TAE) and LC Bead LUMI in people with Hepatic Cancer and Liver Neoplasms, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: Liver cancer begins in the cells of the liver. It can be treated with chemotherapy, radiation, or even a liver transplant. A less invasive treatment may be able to help some people with liver cancer. It is called percutaneous transarterial embolization (TAE). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hepatic Cancer, Liver Neoplasms, Hepatocellular Cancer
- What is being tested?
- Transarterial embolization (TAE) and LC Bead LUMI
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2016to 23 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are determined to be eligible for TAE by an interventional radiologist and the primary/referring team will be eligible for the study.
- Patients with pathologically proven hepatic-dominant neoplasm that might otherwise be candidates for standard clinical TAE.
- Extent of hepatic metastases is <50% of total hepatic volume.
- At least >=18 years of age: Because it is exceeding rare for someone under the age of 18 to develop hepatocellular carcinoma, we will exclude patients <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
- ECOG performance status 0-2
- Six months since last treatment with Y90
Show all 16Show fewer
- Patients must have normal or adequate organ and marrow function as defined below:
- Hematology/Absolute Neutrophil Count/ > 1500 / mm^3 without help of Filgrastim or other stimulating growth factors
- Hematology/Platelet Count Patient eligible if platelet count is correctable to >=50,000/mm^3
- Hematology/Hemoglobin Patient eligible if hemoglobin count is correctable to >= 8.0 g/dl
- Serum Chemistry/ALT/AST <= 5 times the upper limit of normal; except in the presence of obstructive liver metastases where ALT/AST may be up to 10 times the upper limit of normal
- Serum Chemistry/Creatinine <1.5x institution upper limit of normal OR creatinine clearance >= 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
- Serum Chemistry/Total Bilirubin <=3 mg/dl
- Serum Chemistry/Prothrombin Time within 2 seconds of the upper limit of normal (INR<=1.8)
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
Who cannot join
- No contraindications to receive iodine products.
- Main Portal Vein Occlusion or other contraindications to chemoembolization
- Patients taking immunosuppressive drugs or unable to come off of ongoing chronic anticoagulation will not be eligible.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection with systemic manifestations, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women and nursing mothers are excluded from this study because of the potential for teratogenic or abortifacient effects of required multiple imaging and associated radiation doses, anesthesia and risks during thermal ablation to the fetus. Enrolled patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Phase II Study Using LC Bead LUMI Radio-Opaque Embolic Beads to Detect and Characterize the Vascularity of Hepatic Tumors During Treatment With Transarterial Embolization (TAE) Alone or Combined With Thermal Ablation
Background:
Liver cancer begins in the cells of the liver. It can be treated with chemotherapy, radiation, or even a liver transplant. A less invasive treatment may be able to help some people with liver cancer. It is called percutaneous transarterial embolization (TAE). For TAE, a material is injected into blood vessels to block the blood flow that is feeding the tumor. Researchers want to test a new material for TAE that may shrink tumors and can be seen on x-ray and CT images. The embolization may sometimes be combined with thermal ablation, or cooking tumors with needles that deliver heat by electricity or microwave.
Read more
Objective:
To test an embolization material called an LC LUMI beads. To see if it can block blood vessels that provide blood to cancerous tumors and to see how the beads look on x-ray and CT images.
Eligibility:
Adults 18-85 years old who have been diagnosed with liver cancer
Design:
Participants will have routine blood tests, physical exams, and x-rays.
Participants will be screened with blood tests, physical exam, and medical history. They will have a computed tomography (CT) scan of the abdomen and pelvis. This will include a contrast drink and a contrast (dye) injected in the veins.
Participants will be admitted to the clinic. They will repeat the screening tests.
Participants may have other tests. These may include x-rays, other scans, or ultrasound.
Participants will be evaluated for general anesthesia.
They will get counseling about the procedure.
Participants will get anesthesia. The LC LUMI beads will be injected into blood vessels. The beads contain iodine, which makes them visible by x-ray and by a CT scan machine.
Participants will have follow-up visits for 12 months. They will have CT scans and/or other radiologic tests.
Read the detailed description
Background:
Hepatocellular Carcinoma (HCC) is the 3rd most common cause of cancer globally with an increasing incidence worldwide.
Management of hepatic malignancies from primary Hepatocellular Carcinoma (HCC) or metastatic disease involves a multidisciplinary approach of surgery and chemotherapy and in the case of HCC, transplant, anti-VEGF sorafenib, or local or regional image guided therapies.
Thermal ablation (RFA or MWA) and transarterial embolization (TAE) are minimally invasive image guided local or regional therapies that have been extensively studied for decades, and more recently and to a lesser extent have been studied together as a combination therapy.
LC Bead LUM^TM, a radiopaque embolic bead product (company code BTG 13-002), is an imageable spherical embolic product that can be visualised by X-ray based imaging (e.g., fluoroscopy and CT).
The beads are non-resorbable microspheres with calibrated size ranges that occlude arteries for the purpose of blocking the blood flow to a target tissue.
LC Bead LUMITM are intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVMs).
Objectives:
To determine the imaging characteristics of radiopaque beads including qualitatively comparing virtual and actual bead perfusion in the treatment of hepatic tumors using bead embolization.
Eligibility:
Treatment eligibility for TAE requires agreement between the Interventional Radiologist reviewing imaging and feasibility of TAE and the patient's NIH primary treatment team who will evaluate the patient's clinical parameters to undergo anesthesia and the TAE and or ablation procedure.
At least >=18 years of age
Patients with pathologically proven, hepatic-dominant neoplasm.
The extent of hepatic metastases is <50% of total hepatic volume.
Past treatment with Y90 must be 6 months from TAE treatment and liver function within NIH institutional limits
ECOG performance status <=2
Patients must have normal organ and marrow function per laboratory parameters
Patients with minor allergies to iodine will also be excluded.
Design:
Number of Participants: 30
Recruitment Time Frame: approximately 2 years
Type of Study: Feasibility study
This is a pilot study to assess the characteristics of radio-opaque bland beads during TAE in the treatment of hepatic malignancies. Patients may also receive thermal ablation treatment in conjunction with TAE if clinically indicated, although comparison of bead treatment with or without thermal ablation is not part of the study s aim.
To compare virtual and actual perfusion characteristics of the LUMI radiopaque beads with CBCT and/or CT. Patients scans will be obtained per TAE standard of care schedule. Other imaging evaluation of this therapy may be performed at regular intervals following completion of treatment, and will be governed by standard conventional imaging regimen post treatment.
The choice of which combination of imaging (CT, Cone beam CT (CBCT), or fluoroscopy) and when to image, will be made by the clinical care team for the patient, based upon multidisciplinary recommendations and NIH Clinical Center customary use and standard of care, and will be purely clinical decisions (not research-related).
The participants will have a diagnosed hepatic malignancy, and be eligible to undergo transarterial embolization and thermal ablation under general anesthesia. The LC LUMI bead will be used in the transarterial embolization procedure.
Follow up will continue for 12 months from the time of initial treatment.
Patients will be evaluated in multidisciplinary GI medical oncology clinic and up to 30 patients will be enrolled to accrue 20 evaluable patients.
- Conditions
- Hepatic Cancer, Liver Neoplasms, Hepatocellular Cancer, Liver Cancer
- Being tested
- Transarterial embolization (TAE), LC Bead LUMI
- Keywords
- Radio-Opaque Bland Beads, Thermal Ablation, Transarterial Embolization
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial embolization (TAE)Procedure or surgery
Transarterial embolization
LC Bead LUMIDevice
LC Bead LUMI has been designed as a radiopaque version of the LC Bead
| Study group | Role | What they receive |
|---|---|---|
| Hepatic tumors bead embolization | Experimental | Participants with diagnosed hepatic malignancy underwent transarterial embolization (TAE) with or without thermal ablation under general anesthesia. The LC LUMI bead were used in the transarterial embolization procedure. Receives: Procedure: Transarterial embolization (TAE); Device: LC Bead LUMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion Characteristics of Imageable Beads Using Cone Beam CT
Perfusion on x-ray was assessed after delivery of transarterial embolization beads. Qualitative geometric analysis of actual and virtual perfusion was performed with data available using custom software analysis after selective injections of image-able beads during transcatheter intra-arterial delivery to the liver. Liver boundary and super selective perfused boundary were segmented and compared for distribution of beads on virtual and actual perfusion for possible match. Analysis was the visibility of beads upon transcatheter intra-arterial delivery to the liver and evaluation of impact on perfusion from subjective evaluation during procedural angiography, and/or cone beam CT. Qualitative analysis was done to determine match for distribution of beads on virtual and actual perfusion.
Measured: Intra-procedure
Perfusion Characteristics of Imageable Beads Using Cone Beam CT
Perfusion on x-ray was assessed after delivery of transarterial embolization beads. Qualitative geometric analysis of actual and virtual perfusion was performed with data available using custom software analysis after selective injections of image-able beads during transcatheter intra-arterial delivery to the liver. Liver boundary and super selective perfused boundary were segmented and compared for distribution of beads on virtual and actual perfusion for possible match. Analysis was the visibility of beads upon transcatheter intra-arterial delivery to the liver and evaluation of impact on perfusion from subjective evaluation during procedural angiography, and/or cone beam CT. Qualitative analysis was done to determine match for distribution of beads on virtual and actual perfusion
Measured: One year post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study start12 Jan 2016
- Primary completion23 Jul 2020
- Study completion23 Jul 2020
Why it stopped: unavailability of study device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Bradford J Wood, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649868
- Sponsor's protocol ID
- 160049
- Other IDs
- 16-CC-0049
- Status last verified
- Apr 2024
- First submitted
- 7 Jan 2016
- Last updated
- 11 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: .Plan to share human data generated in this research for future research as follows: * De-identified data in BTRIS * De-identified or identified data with approved outside collaborators under appropriate agreements
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Using LC Bead LUMI Radio-Opaque Embolic Beads to Detect and Characterize the Vascularity of Hepatic Tumors During Treatment With Transarterial Embolization (TAE) Alone or Combined With Thermal Ablation
- ClinicalTrials.gov ID
- NCT02649868
- Acronym / sponsor ID
- 160049
- Conditions
- Hepatic Cancer, Liver Neoplasms, Hepatocellular Cancer, Liver Cancer
- Keywords
- Radio-Opaque Bland Beads, Thermal Ablation, Transarterial Embolization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unavailability of study device
- Enrolment
- 19 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 12 Jan 2016 (actual)
- Primary completion
- 23 Jul 2020 (actual)
- Study completion
- 23 Jul 2020 (actual)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Posted 11 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Liver cancer begins in the cells of the liver. It can be treated with chemotherapy, radiation, or even a liver transplant. A less invasive treatment may be able to help some people with liver cancer. It is called percutaneous transarterial embolization (TAE). For TAE, a material is injected into blood vessels to block the blood flow that is feeding the tumor. Researchers want to test a new material for TAE that may shrink tumors and can be seen on x-ray and CT images. The embolization may sometimes be combined with thermal ablation, or cooking tumors with needles that deliver heat by electricity or microwave.
Objective:
To test an embolization material called an LC LUMI beads. To see if it can block blood vessels that provide blood to cancerous tumors and to see how the beads look on x-ray and CT images.
Eligibility:
Adults 18-85 years old who have been diagnosed with liver cancer
Design:
Participants will have routine blood tests, physical exams, and x-rays.
Participants will be screened with blood tests, physical exam, and medical history. They will have a computed tomography (CT) scan of the abdomen and pelvis. This will include a contrast drink and a contrast (dye) injected in the veins.
Participants will be admitted to the clinic. They will repeat the screening tests.
Participants may have other tests. These may include x-rays, other scans, or ultrasound.
Participants will be evaluated for general anesthesia.
They will get counseling about the procedure.
Participants will get anesthesia. The LC LUMI beads will be injected into blood vessels. The beads contain iodine, which makes them visible by x-ray and by a CT scan machine.
Participants will have follow-up visits for 12 months. They will have CT scans and/or other radiologic tests.
Detailed description
Background:
Hepatocellular Carcinoma (HCC) is the 3rd most common cause of cancer globally with an increasing incidence worldwide.
Management of hepatic malignancies from primary Hepatocellular Carcinoma (HCC) or metastatic disease involves a multidisciplinary approach of surgery and chemotherapy and in the case of HCC, transplant, anti-VEGF sorafenib, or local or regional image guided therapies.
Thermal ablation (RFA or MWA) and transarterial embolization (TAE) are minimally invasive image guided local or regional therapies that have been extensively studied for decades, and more recently and to a lesser extent have been studied together as a combination therapy.
LC Bead LUM^TM, a radiopaque embolic bead product (company code BTG 13-002), is an imageable spherical embolic product that can be visualised by X-ray based imaging (e.g., fluoroscopy and CT).
The beads are non-resorbable microspheres with calibrated size ranges that occlude arteries for the purpose of blocking the blood flow to a target tissue.
LC Bead LUMITM are intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVMs).
Objectives:
To determine the imaging characteristics of radiopaque beads including qualitatively comparing virtual and actual bead perfusion in the treatment of hepatic tumors using bead embolization.
Eligibility:
Treatment eligibility for TAE requires agreement between the Interventional Radiologist reviewing imaging and feasibility of TAE and the patient's NIH primary treatment team who will evaluate the patient's clinical parameters to undergo anesthesia and the TAE and or ablation procedure.
At least >=18 years of age
Patients with pathologically proven, hepatic-dominant neoplasm.
The extent of hepatic metastases is <50% of total hepatic volume.
Past treatment with Y90 must be 6 months from TAE treatment and liver function within NIH institutional limits
ECOG performance status <=2
Patients must have normal organ and marrow function per laboratory parameters
Patients with minor allergies to iodine will also be excluded.
Design:
Number of Participants: 30
Recruitment Time Frame: approximately 2 years
Type of Study: Feasibility study
This is a pilot study to assess the characteristics of radio-opaque bland beads during TAE in the treatment of hepatic malignancies. Patients may also receive thermal ablation treatment in conjunction with TAE if clinically indicated, although comparison of bead treatment with or without thermal ablation is not part of the study s aim.
To compare virtual and actual perfusion characteristics of the LUMI radiopaque beads with CBCT and/or CT. Patients scans will be obtained per TAE standard of care schedule. Other imaging evaluation of this therapy may be performed at regular intervals following completion of treatment, and will be governed by standard conventional imaging regimen post treatment.
The choice of which combination of imaging (CT, Cone beam CT (CBCT), or fluoroscopy) and when to image, will be made by the clinical care team for the patient, based upon multidisciplinary recommendations and NIH Clinical Center customary use and standard of care, and will be purely clinical decisions (not research-related).
The participants will have a diagnosed hepatic malignancy, and be eligible to undergo transarterial embolization and thermal ablation under general anesthesia. The LC LUMI bead will be used in the transarterial embolization procedure.
Follow up will continue for 12 months from the time of initial treatment.
Patients will be evaluated in multidisciplinary GI medical oncology clinic and up to 30 patients will be enrolled to accrue 20 evaluable patients.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatic tumors bead embolization | Experimental | Procedure: Transarterial embolization (TAE), Device: LC Bead LUMIParticipants with diagnosed hepatic malignancy underwent transarterial embolization (TAE) with or without thermal ablation under general anesthesia. The LC LUMI bead were used in the transarterial embolization procedure. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients who are determined to be eligible for TAE by an interventional radiologist and the primary/referring team will be eligible for the study.
- Patients with pathologically proven hepatic-dominant neoplasm that might otherwise be candidates for standard clinical TAE.
- Extent of hepatic metastases is <50% of total hepatic volume.
- At least >=18 years of age: Because it is exceeding rare for someone under the age of 18 to develop hepatocellular carcinoma, we will exclude patients <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
- ECOG performance status 0-2
Key exclusion criteria (5 listed)
- No contraindications to receive iodine products.
- Main Portal Vein Occlusion or other contraindications to chemoembolization
- Patients taking immunosuppressive drugs or unable to come off of ongoing chronic anticoagulation will not be eligible.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection with systemic manifestations, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women and nursing mothers are excluded from this study because of the potential for teratogenic or abortifacient effects of required multiple imaging and associated radiation doses, anesthesia and risks during thermal ablation to the fetus. Enrolled patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transarterial embolization (TAE)Transarterial embolization | Procedure or surgery | Hepatic tumors bead embolization |
| LC Bead LUMILC Bead LUMI has been designed as a radiopaque version of the LC Bead | Device | Hepatic tumors bead embolization |
Primary outcome
Perfusion Characteristics of Imageable Beads Using Cone Beam CT
Time frame: Intra-procedure
Perfusion on x-ray was assessed after delivery of transarterial embolization beads. Qualitative geometric analysis of actual and virtual perfusion was performed with data available using custom software analysis after selective injections of image-able beads during transcatheter intra-arterial delivery to the liver. Liver boundary and super selective perfused boundary were segmented and compared for distribution of beads on virtual and actual perfusion for possible match. Analysis was the visibility of beads upon transcatheter intra-arterial delivery to the liver and evaluation of impact on perfusion from subjective evaluation during procedural angiography, and/or cone beam CT. Qualitative analysis was done to determine match for distribution of beads on virtual and actual perfusion.
Perfusion Characteristics of Imageable Beads Using Cone Beam CT
Time frame: One year post procedure
Perfusion on x-ray was assessed after delivery of transarterial embolization beads. Qualitative geometric analysis of actual and virtual perfusion was performed with data available using custom software analysis after selective injections of image-able beads during transcatheter intra-arterial delivery to the liver. Liver boundary and super selective perfused boundary were segmented and compared for distribution of beads on virtual and actual perfusion for possible match. Analysis was the visibility of beads upon transcatheter intra-arterial delivery to the liver and evaluation of impact on perfusion from subjective evaluation during procedural angiography, and/or cone beam CT. Qualitative analysis was done to determine match for distribution of beads on virtual and actual perfusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. .Plan to share human data generated in this research for future research as follows: * De-identified data in BTRIS * De-identified or identified data with approved outside collaborators under appropriate agreements
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradford J Wood, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transarterial embolization (TAE) and LC Bead LUMI in people with Hepatic Cancer and Liver Neoplasms, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion Characteristics of Imageable Beads Using Cone Beam CT (time frame: Intra-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.